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Completed

NCT Number: NCT03026296

Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study

A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service providing lifestyle support programs for physical activity, smoking cessation and diet, to inhabitants with increased risk for development of non-communicable diseases. HLCs intention is to reach physically inactive people who need guidance to get more physically active, and offer them a lifestyle program for three months or more.

The main aim of this study is to study whether the HLCs, organized according to the Norwegian Directorate of Health's guidelines for municipal healthy life centers, affects the participants short term (3 months) and long term (15 months) physical activity level. Also changes in diet, tobacco use, health related quality of life, physical fitness, anthropometry, self-efficacy, motivation, drug use, use of health services and work participation will be assessed. Secondary aim is to study whether there are any moderators, such as HLCs capacity, expertise, and collaboration with other services, that have significance for participants' change. Also it will be studied whether the HLCs result in larger changes in some subgroups (e.g. socioeconomic) of participants than in others.

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Key information

Conditions

Musculoskeletal Disease Behavior Body Weight Health Behavior Mental Disorders Motor Activity Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psychological Disorder Signs and Symptoms Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frisklivssentrale, Drammen (plus 9 More Communities), Buskerud, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • about to start structural support for lifestyle change (regarding physical activity, diet and/or tobacco cessation
  • referred to a Healthy Life Center (HLC) from either primary physician, from other health care services or social services, or participants seeking contact themselves without a specific referral.

Exclusion criteria

  • having participated in an HLC the previous 6 months

Treatment and study plan

Healthy Life Center

Behavioral

Depending on what behavior participants aim to change, they get individual counselling using elements from motivational interviewing, group-based exercise twice a week, diet courses and tobacco secession courses during three months

Other names: Frisklivssentralen (Norwegian)

Primary outcomes

  1. physical activity

    Time frame: change from baseline to 3 months

    measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

  2. physical activity

    Time frame: change from 3 months to 15 months

    measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

Secondary outcomes

  1. Physical activity

    Time frame: change from baseline to 3 months

    assessed by questionnaire

  2. Physical activity

    Time frame: change from 3 months to 15 months

    assessed by questionnaire

  3. health related quality of life

    Time frame: change from baseline to 3 months

    assessed by SF-36 questionnaire

  4. health related quality of life

    Time frame: change from 3 months to 15 months

    assessed by SF-36 questionnaire

  5. Diet

    Time frame: change from baseline to 3 months

    assessed by questionnaire

  6. Diet

    Time frame: change from 3 months to 15 months

    assessed by questionnaire

  7. Tobacco use

    Time frame: change from baseline to 3 months

    assessed by questionnaire

  8. Tobacco use

    Time frame: change from 3 months to 15 months

    assessed by questionnaire

  9. Physical fitness

    Time frame: change from baseline to 3 months

    assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

  10. Physical fitness

    Time frame: change from 3 months to 15 months

    assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

  11. Body weight

    Time frame: change from baseline to 3 months

    measured on a scale digital weight

  12. Body weight

    Time frame: change from 3 months to 15 months

    measured on a scale digital weight

  13. Body Mass Index

    Time frame: change from baseline to 3 months

    body height measured by a Seca altimeter

  14. Body Mass Index

    Time frame: change from 3 months to 15 months

    body height measured by a Seca altimeter

  15. Waist circumference

    Time frame: change from baseline to 3 months

    measured by Seca measurement tape

  16. Waist circumference

    Time frame: change from 3 months to 15 months

    measured by Seca measurement tape

  17. Hip circumference

    Time frame: change from baseline to 3 months

    measured by Seca measurement tape

  18. Hip circumference

    Time frame: change from 3 months to 15 months

    measured by Seca measurement tape

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Western Norway University of Applied Sciences

Registry information

Official study title

Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study on Changes Among Participants and Moderators for Changes Such as the Centers Capacity and Competence and the Participants Motivation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2017
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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